Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study
Alexa Henderson
Summary
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age. Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin. Participants will: * Be randomly assigned to one of two groups: * The standard antibiotic treatment * The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day. * Participants will be asked to complete a survey regarding their experience and side effects.
Description
Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Singleton gestation * Gestational age at time of PPROM between 22w0d and 28w0d * Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care) * Remain pregnant 48 hours after presentation. * Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included. * Pregnant patients below the age of 18 are eligible. Exclusion Criteria: * Contraindications to expectant management (clinical intra-amniotic in…
Interventions
- DrugAzithromycin (Azithro)
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
- DrugStandard Azithromycin Dosing
Oral Azithromycin 1g once.
Location
- University of Pittsburgh Magee-Womens HospitalPittsburgh, Pennsylvania